Compliance to Vaccination in Children With Diabetes and Their Siblings

N/ACompletedNCT07471906

Aristotle University Of Thessaloniki60 enrolled

Overview

This is an observational, single-center, cross-sectional study about adherence to both obligatory and recommended vaccination in children with Type 1 Diabetes Mellitus and their siblings.

A great amount of discussion has been made regarding the possible association between routine vaccinations and the risk of childhood type 1 diabetes mellitus. This study is designed to explore the level of compliance to obligatory and recommended vaccinations in children after being diagnosed with Type 1 Diabetes Mellitus and their siblings.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes

Interventions

Compliance to vaccination scheduleBEHAVIORAL

Record the percentage of performed vaccination / required vaccination

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Willingness to participate in the study 2. Informed consent obtained by parents or legal caregivers before any trial-related activities. 3. Documented diagnosis of tyoe 1 Diabetes mellitus in one children of the family 4. Written documents on vaccination schedules in participating subjects (children with Type 1 Diabetes and siblings) Exclusion Criteria: 1\. Communication problems

Locations (1)

Aristotle University of Thessaloniki

Thessaloniki, Greece

Outcomes

Primary Outcomes

Change in Time in Range (TIR) in children with T1D after switching to ultra-rapid insulin aspart

Percentage of time that interstitial glucose levels are between 70-180 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).

Time frame: 3-6 months after insulin switch

Secondary Outcomes

Change in Time Above Range (TAR) after switching to ultra-rapid insulin aspart

Percentage of time that interstitial glucose levels are above 180 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).

Time frame: 3-6 months after switching insulin

Change in Glycated Hemoglobin (A1c) after switching to ultra-rapid insulin aspart

Mean HbA1c (%) calculated from laboratory measurements over the 12 months before and after insulin switch

Time frame: 12 months

Change in Time Below Range (TBR) after switching to ultra-rapid insulin aspart

Percentage of time that interstitial glucose levels are below 70 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).

Time frame: 3-6 months after switching insulin

Change in total daily insulin dose and basal/bolus proportions

Total daily insulin (U/kg/day) and percentage of basal and bolus insulin, obtained from clinical records before and after switching to ultra-rapid insulin aspart.

Time frame: 3-6 months after switching insulin

Data from ClinicalTrials.gov

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